Congenital HyperinsulinismPhase 2NCT04538989
An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism
A Phase 2 study testing RZ358 Sequential Group Cohort 1, RZ358 Sequential Group Cohort 2 and RZ358 Sequential Group Cohort 3 in people with Congenital Hyperinsulinism, run by Rezolute at 17 sites in 11 countries.
Trial summary
The objective of this trial is to evaluate the safety, tolerability and glucose-raising effects of RZ358 in patients with Congenital Hyperinsulinism (HI). Read more about this study
- Who is it for?
- Ages 2 to 45 years
- Conditions the study is for
- Congenital Hyperinsulinism
- What is being tested?
- RZ358 Sequential Group Cohort 1, RZ358 Sequential Group Cohort 2 and RZ358 Sequential Group Cohort 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 17 sitesin 11 countries
- Study dates
- 24 Feb 2020to 19 Aug 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female age 2-45 years old (except age 12-45 in US) with an established clinical diagnosis of congenital hyperinsulinism
- Able to provide written informed consent or, as applicable, assent
- Confirmed hypoglycemia as assessed by CGM, SMBG, and clinical evaluation, during Screening
- Willingness to use contraception if of child-bearing potential
Who cannot join
- Out of range blood work for study entry
- Body Mass index outside of study entry criteria
- History of malignancy
- Clinically significant diseases, seropositivity for HIV, hepatitis B or C antibody
- Use of systemic corticosteroids within 30 days before Screening
- Known or suspected allergy to the study drug
Show all 9Show fewer
- Recent use of an investigational drug or treatment, or participation in an investigational study
- Pregnant or lactating women
- History of drug abuse or excessive alcohol use
Trial locations and contacts
17 sites in 11 countries.
17 sites in 11 countries
Turkey (Türkiye)4 sites
Hacettepe University
Çankaya, Ankara, 06800
SBÜ Gazi Yaşargil Eğitim ve Araştirma Hastanesi
Kayapınar, Diyarbakır, 21070
Adana Cukurova University Balcalı Hospital
Sarıçam, Adana
Erzurum City Hospital
Yakutiye, Erzurum
United States2 sites
Cook Children's Medical Center
Fort Worth, Texas, 76104
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Bulgaria2 sites
SHAT Children diseases "Prof. Dr. Ivan Mitov"
Sofia
Medical University of Varna UMHAT "St. Marina"
Varna, 9010
Israel2 sites
Hadassah Har Hazofim MC - Division of Pediatric Endocrinology
Jerusalem, 90000
Edmond & Lilly Safra's Children Hospital
Ramat Gan, Tel-Hashomer, 5265601
Canada1 site
Research Institute of the McGill University Health Centre
Monteral, Qubec, H4A 3J1
Germany1 site
Magdeburg University Clinic Center (Otto-von-Guericke Universität)
Magdeburg, 39120
About this study
Official title: An Open-Label Multiple-Dose Study of RZ358 in Patients With Congenital Hyperinsulinism
The objective of this trial is to evaluate the safety, tolerability and glucose-raising effects of RZ358 in patients with Congenital Hyperinsulinism (HI).
Read the detailed description
There is a significant unmet medical need to develop new therapies aimed at preventing chronic recurrent hypoglycemia in congenital HI, the most common cause of persistent hypoglycemia in children. RZ358 is a human mAb that allosterically attenuates excessive insulin action on target cells. Therefore, RZ358 is ideally suited as a potential therapy for hyperinsulinism, and it is being developed to treat the hypoglycemia associated with diseases such as congenital HI. This is a Phase 2, multicenter, open label clinical study designed to assess the safety and efficacy of four progressively higher doses of RZ358 in separate groups of patients with hyperinsulinemic hypoglycemia due to Congenital HI, not adequately controlled with or without current standard of care. A screening period of up to 5 weeks will evaluate eligibility. Once enrolled, RZ358 will be administered bi-weekly over 8 weeks, and then patients will complete a post-treatment follow-up period of 13 weeks.
- Conditions
- Congenital Hyperinsulinism
- Being tested
- RZ358 Sequential Group Cohort 1, RZ358 Sequential Group Cohort 2, RZ358 Sequential Group Cohort 3, RZ358 Sequential Group Cohort 4
- Keywords
- Hypoglycemia, Congenital Hyperinsulinism, Glucose Metabolism Disorders, Metabolic Diseases, Pancreatic Diseases, Digestive System Diseases, Hyperinsulinism
- Medical subject headings
- Congenital Hyperinsulinism, Hypoglycemia, Glucose Metabolism Disorders, Metabolic Diseases, Pancreatic Diseases, Digestive System Diseases, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RZ358 Sequential Group Cohort 1Drug
IV infusion for 8 weeks (3 mg/kg bi-weekly for 8 weeks)
RZ358 Sequential Group Cohort 2Drug
IV infusion for 8 weeks (6 mg/kg bi-weekly for 8 weeks)
RZ358 Sequential Group Cohort 3Drug
IV infusion for 8 weeks (9 mg/kg bi-weekly for 8 weeks)
RZ358 Sequential Group Cohort 4Drug
IV infusion for 8 weeks (bi-weekly fixed dose-titration from 3 to 9 mg/kg for the first 4 weeks, followed by a fixed 9 mg/kg dose amount thereafter for the remaining 4 weeks)
| Study group | Role | What they receive |
|---|---|---|
| RZ358 Cohort 1 | Experimental | Not described Receives: Drug: RZ358 Sequential Group Cohort 1 |
| RZ358 Cohort 2 | Experimental | Not described Receives: Drug: RZ358 Sequential Group Cohort 2 |
| RZ358 Cohort 3 | Experimental | Not described Receives: Drug: RZ358 Sequential Group Cohort 3 |
| RZ358 Cohort 4 | Experimental | Not described Receives: Drug: RZ358 Sequential Group Cohort 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median of Average Daily Percent Time Within a Glucose Target Range of 70-180 mg/dL (3.9-10 mmol/L) by CGM at Baseline (BL) and End of Treatment (EOT)
The median of average daily percent time within the glucose target range 70-180 mg/dL (3.9-10 mmol/L) by CGM at Baseline and End of Treatment (EOT) is reported.
Measured: 8 weeks
Median Percent Change of Average Daily Percent Time Within a Glucose Target Range of 70-180 mg/dL (3.9-10 mmol/L) by CGM From Baseline (BL)
The average daily percent time within the glucose target range (70-180 mg/dL) is compared from baseline to end of treatment (EOT) and the median percent change of that difference is reported.
Measured: 8 weeks
Repeat Dose Pharmacokinetics of RZ358
All patients who received RZ358 and for whom the primary PK data was considered to be sufficient and interpretable were to be included in the PK analyses. Individual and mean plasma concentration data is summarized descriptively at the specified timepoints. The results of this study may be combined with those of other studies for analysis and modeling (e.g., population PK and PK-PD), and therefore the PK parameters are reported separately, as part of an iterative population PK approach.
Measured: Pre dose Weeks 1,3,5,7, 1-hr post dose Week 1 and Week 7, and Follow up on Days 14, Day 28, Day 42, and Day 105
Secondary outcomes (11)
Median of Average Weekly Overall, Moderate, and Severe Hypoglycemia Events by SMBG at Baseline (BL) and End of Treatment (EOT)
The median of average weekly number of overall hypoglycemia events (<70 mg/dL [3.9mmol/L], moderate hypoglycemia events (<60 mg/dL [3.3 mmol/L] and severe hypoglycemia events (<50 mg/dL [2.8mmol/L]) by SMBG at baseline (BL) and end of treatment (EOT) is reported.
Measured: 8 weeks
Median Percent Change of Average Weekly Overall, Moderate, and Severe Hypoglycemia Events by SMBG From Baseline (BL)
The average weekly number overall hypoglycemia events (<70 mg/dL [3.9mmol/L], moderate hypoglycemia events (<60 mg/dL [3.3 mmol/L] and severe hypoglycemia events (<50 mg/dL [2.8mmol/L]) by SMBG is compared from baseline (BL) to end of treatment (EOT) and the median percent changes of those differences are reported.
Measured: 8 weeks
Median of Average Daily Percent Time With Overall, Moderate, and Severe Hypoglycemia by CGM at Baseline (BL) and End of Treatment (EOT)
The median of average daily percent time in overall (<70 mg/dL [<3.9 mmol/L]), moderate (<60 mg/dL [3.3 mmol/L]), and severe (<50 mg/dL [2.8 mmol/L]) hypoglycemia at baseline (BL) and end of treatment (EOT) is reported.
Measured: 8 weeks
Median Percent Change of Average Daily Percent Time With Overall, Moderate, and Severe Hypoglycemia by CGM From Baseline (BL)
The average daily percent time in overall (<70 mg/dL [<3.9 mmol/L]), moderate (<60 mg/dL [3.3 mmol/L]), and severe (<50 mg/dL [2.8 mmol/L]) hypoglycemia is compared from baseline (BL) to end of treatment (EOT) and the median percent changes of those differences are reported.
Measured: 8 weeks
Median of Average Daily Duration (Minutes) With Overall, Moderate, and Severe Hypoglycemia by CGM at Baseline (BL) and End of Treatment (EOT)
The median of average duration (minutes) in overall (<70 mg/dL [<3.9 mmol/L]), moderate (<60 mg/dL [3.3 mmol/L] ), and severe (<50 mg/dL [2.8 mmol/L]) hypoglycemia by CGM at baseline (BL) and end of treatment (EOT) is reported.
Measured: 8 weeks
Median Percent Change of Average Daily Duration (Minutes) With Overall, Moderate, and Severe Hypoglycemia by CGM From Baseline (BL)
The average duration (minutes) in overall (<70 mg/dL [<3.9 mmol/L]), moderate (<60 mg/dL [3.3 mmol/L] ), and severe (<50 mg/dL [2.8 mmol/L]) hypoglycemia by CGM is compared from baseline (BL) to end of treatment (EOT) and the median percent changes of those differences are reported.
Measured: 8 weeks
Occurrence of Hypoglycemia During Fasting Challenge
The occurrence of hypoglycemia during a 12 Hour fasting challenge.
Measured: 8 Weeks
Median of Average Hypoglycemia Events Per Day at Each of the Specified Glucose Thresholds by CGM at Baseline (BL) and End of Treatment (EOT)
The median of average hypoglycemia events per day at each of the specified glucose thresholds [<70, <60, and <50 mg/dL (3.9, 3.3, and 2.8 mmol/L)], by CGM at baseline (BL) and end of treatment (EOT) is reported.
Measured: 8 weeks
Median Net Change of Average Hypoglycemia Events Per Day at Each of the Specified Glucose Thresholds by CGM From Baseline (BL)
The average hypoglycemia events per day at each of the specified glucose thresholds [<70, <60, and <50 mg/dL (3.9, 3.3, and 2.8 mmol/L)], by CGM is compared from baseline (BL) to end of treatment (EOT) and the median net changes of those differences are reported.
Measured: 8 weeks
Median of Average 8-hour Overnight Percent Time in Glucose Target Range of 70-180mg/dL by CGM at Baseline (BL) and End of Treatment (EOT)
The median of average 8-hour overnight (12am-8am) percent time within the glucose target range (70-180 mg/dL) at baseline (BL) and end of treatment (EOT) is reported.
Measured: 8 weeks
Median Percent Change of Average 8-hour Overnight Percent Time in Glucose Target Range of 70-180mg/dL by CGM From Baseline (BL)
The average 8-hour overnight (12am-8am) percent time within the glucose target range (70-180 mg/dL) is compared from baseline (BL) to end of treeatment (EOT) and the median percent change of that difference is reported.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start24 Feb 2020
- Primary completion5 Apr 2022
- Study completion19 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital HyperinsulinismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rezolute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538989
- Sponsor's protocol ID
- RZ358-606
- Status last verified
- May 2025
- First submitted
- 21 Aug 2020
- Last updated
- 28 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Demirbilek H, Melikyan M, Iotova V, Galcheva S, Ozbek MN, Dastamani A, Kheladze N, Mazor-Aronovitch K, Clemente M, Empting S, Mohnike K, Christesen HT, Thornton PS, De Leon DD, Hood D, O'Boyle E, Roberts BK. Global, multi-center, repeat-dose, phase 2 study of RZ358 (ersodetug), an insulin receptor antibody, for congenital hyperinsulinism. Med. 2025 Jun 13;6(6):100611. doi: 10.1016/j.medj.2025.100611. Epub 2025 Mar 18.
PubMed 40107271
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Multiple-Dose Study of RZ358 in Patients With Congenital Hyperinsulinism
- ClinicalTrials.gov ID
- NCT04538989
- Acronym / sponsor ID
- RZ358-606
- Conditions
- Congenital Hyperinsulinism
- Keywords
- Hypoglycemia, Congenital Hyperinsulinism, Glucose Metabolism Disorders, Metabolic Diseases, Pancreatic Diseases, Digestive System Diseases, Hyperinsulinism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- RezoluteUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 4 Sep 2020 (actual)
- Results
- Posted 28 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial is to evaluate the safety, tolerability and glucose-raising effects of RZ358 in patients with Congenital Hyperinsulinism (HI).
Detailed description
There is a significant unmet medical need to develop new therapies aimed at preventing chronic recurrent hypoglycemia in congenital HI, the most common cause of persistent hypoglycemia in children. RZ358 is a human mAb that allosterically attenuates excessive insulin action on target cells. Therefore, RZ358 is ideally suited as a potential therapy for hyperinsulinism, and it is being developed to treat the hypoglycemia associated with diseases such as congenital HI. This is a Phase 2, multicenter, open label clinical study designed to assess the safety and efficacy of four progressively higher doses of RZ358 in separate groups of patients with hyperinsulinemic hypoglycemia due to Congenital HI, not adequately controlled with or without current standard of care. A screening period of up to 5 weeks will evaluate eligibility. Once enrolled, RZ358 will be administered bi-weekly over 8 weeks, and then patients will complete a post-treatment follow-up period of 13 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RZ358 Cohort 1 | Experimental | Drug: RZ358 Sequential Group Cohort 1 |
| RZ358 Cohort 2 | Experimental | Drug: RZ358 Sequential Group Cohort 2 |
| RZ358 Cohort 3 | Experimental | Drug: RZ358 Sequential Group Cohort 3 |
| RZ358 Cohort 4 | Experimental | Drug: RZ358 Sequential Group Cohort 4 |
Who may qualify
- Ages
- 2 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male or female age 2-45 years old (except age 12-45 in US) with an established clinical diagnosis of congenital hyperinsulinism
- Able to provide written informed consent or, as applicable, assent
- Confirmed hypoglycemia as assessed by CGM, SMBG, and clinical evaluation, during Screening
- Willingness to use contraception if of child-bearing potential
Key exclusion criteria (9 listed)
- Out of range blood work for study entry
- Body Mass index outside of study entry criteria
- History of malignancy
- Clinically significant diseases, seropositivity for HIV, hepatitis B or C antibody
- Use of systemic corticosteroids within 30 days before Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RZ358 Sequential Group Cohort 1IV infusion for 8 weeks (3 mg/kg bi-weekly for 8 weeks) | Drug | RZ358 Cohort 1 |
| RZ358 Sequential Group Cohort 2IV infusion for 8 weeks (6 mg/kg bi-weekly for 8 weeks) | Drug | RZ358 Cohort 2 |
| RZ358 Sequential Group Cohort 3IV infusion for 8 weeks (9 mg/kg bi-weekly for 8 weeks) | Drug | RZ358 Cohort 3 |
| RZ358 Sequential Group Cohort 4IV infusion for 8 weeks (bi-weekly fixed dose-titration from 3 to 9 mg/kg for the first 4 weeks, followed by a fixed 9 mg/kg dose amount thereafter for the remaining 4 weeks) | Drug | RZ358 Cohort 4 |
Primary outcome
Median of Average Daily Percent Time Within a Glucose Target Range of 70-180 mg/dL (3.9-10 mmol/L) by CGM at Baseline (BL) and End of Treatment (EOT)
Time frame: 8 weeks
The median of average daily percent time within the glucose target range 70-180 mg/dL (3.9-10 mmol/L) by CGM at Baseline and End of Treatment (EOT) is reported.
Median Percent Change of Average Daily Percent Time Within a Glucose Target Range of 70-180 mg/dL (3.9-10 mmol/L) by CGM From Baseline (BL)
Time frame: 8 weeks
The average daily percent time within the glucose target range (70-180 mg/dL) is compared from baseline to end of treatment (EOT) and the median percent change of that difference is reported.
Repeat Dose Pharmacokinetics of RZ358
Time frame: Pre dose Weeks 1,3,5,7, 1-hr post dose Week 1 and Week 7, and Follow up on Days 14, Day 28, Day 42, and Day 105
All patients who received RZ358 and for whom the primary PK data was considered to be sufficient and interpretable were to be included in the PK analyses. Individual and mean plasma concentration data is summarized descriptively at the specified timepoints. The results of this study may be combined with those of other studies for analysis and modeling (e.g., population PK and PK-PD), and therefore the PK parameters are reported separately, as part of an iterative population PK approach.
11 secondary outcomes
Median of Average Weekly Overall, Moderate, and Severe Hypoglycemia Events by SMBG at Baseline (BL) and End of Treatment (EOT)
Time frame: 8 weeks
Median Percent Change of Average Weekly Overall, Moderate, and Severe Hypoglycemia Events by SMBG From Baseline (BL)
Time frame: 8 weeks
Median of Average Daily Percent Time With Overall, Moderate, and Severe Hypoglycemia by CGM at Baseline (BL) and End of Treatment (EOT)
Time frame: 8 weeks
Median Percent Change of Average Daily Percent Time With Overall, Moderate, and Severe Hypoglycemia by CGM From Baseline (BL)
Time frame: 8 weeks
Median of Average Daily Duration (Minutes) With Overall, Moderate, and Severe Hypoglycemia by CGM at Baseline (BL) and End of Treatment (EOT)
Time frame: 8 weeks
Median Percent Change of Average Daily Duration (Minutes) With Overall, Moderate, and Severe Hypoglycemia by CGM From Baseline (BL)
Time frame: 8 weeks
Occurrence of Hypoglycemia During Fasting Challenge
Time frame: 8 Weeks
Median of Average Hypoglycemia Events Per Day at Each of the Specified Glucose Thresholds by CGM at Baseline (BL) and End of Treatment (EOT)
Time frame: 8 weeks
Median Net Change of Average Hypoglycemia Events Per Day at Each of the Specified Glucose Thresholds by CGM From Baseline (BL)
Time frame: 8 weeks
Median of Average 8-hour Overnight Percent Time in Glucose Target Range of 70-180mg/dL by CGM at Baseline (BL) and End of Treatment (EOT)
Time frame: 8 weeks
Median Percent Change of Average 8-hour Overnight Percent Time in Glucose Target Range of 70-180mg/dL by CGM From Baseline (BL)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40107271Demirbilek H, Melikyan M, Iotova V, Galcheva S, Ozbek MN, Dastamani A, Kheladze N, Mazor-Aronovitch K, Clemente M, Empting S, Mohnike K, Christesen HT, Thornton PS, De Leon DD, Hood D, O'Boyle E, Roberts BK. Global, multi-center, repeat-dose, phase 2 study of RZ358 (ersodetug), an insulin receptor antibody, for congenital hyperinsulinism. Med. 2025 Jun 13;6(6):100611. doi: 10.1016/j.medj.2025.100611. Epub 2025 Mar 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RZ358 Sequential Group Cohort 1, RZ358 Sequential Group Cohort 2 and RZ358 Sequential Group Cohort 3 in people with Congenital Hyperinsulinism, run by Rezolute at 17 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Turkey (Türkiye), United States, Bulgaria, Israel, Canada and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median of Average Daily Percent Time Within a Glucose Target Range of 70-180 mg/dL (3.9-10 mmol/L) by CGM at Baseline (BL) and End of Treatment (EOT) (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04538989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.